Oral Alkylating Agent – Antineoplastic Chemotherapy

ATC Code: L01AX03 | Prescription Only | Cytotoxic

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Product Description:

Temozolomide is an oral imidazotetrazine-derived alkylating agent that exerts cytotoxic effects by methylating DNA at the O6 and N7 positions of guanine. It is a prodrug, quickly converted under physiological pH to the active molecule MTIC (monomethyl triazeno imidazole carboxamide), which disrupts DNA replication and leads to tumor cell apoptosis. It is primarily indicated for the treatment of high-grade gliomas, including glioblastoma multiforme and anaplastic astrocytoma.

Available Presentation:

• Strength: 20 mg per capsule
• Formulation: Hard gelatin capsule (color-coded by manufacturer)
• Packaging: Blister packs or HDPE bottles, usually with 5, 14, or 20 capsules
• Administration: Oral
• Storage: Store below 30°C; protect from light and moisture
• Handling: Cytotoxic precautions required

Uses:

• First-line therapy for glioblastoma multiforme (GBM):
  • Concurrent with radiotherapy
  • Followed by adjuvant monotherapy
• Treatment of anaplastic astrocytoma in relapsed settings
• Investigational uses in:
  • Metastatic melanoma
  • Neuroendocrine tumors
  • Pediatric CNS tumors (under expert protocols)

Indications:

• Glioblastoma Multiforme (GBM):
  • In combination with radiotherapy
  • Maintenance monotherapy in newly diagnosed patients
• Anaplastic Astrocytoma: Recurrent or progressive disease
• Pediatric Oncology: High-grade CNS tumors under specific oncology protocols
• Other Uses: Off-label applications under specialist management

Regulatory and Safety Profile:

• ATC Code: L01AX03
• Pregnancy Category: D – Use only if clearly indicated
• Black Box Warnings: Myelosuppression, including severe neutropenia and thrombocytopenia
• Common Side Effects: Nausea, vomiting, fatigue, constipation, alopecia, lymphopenia
• Severe Risks: Opportunistic infections (e.g., PCP), hepatotoxicity, secondary cancers
• Monitoring: Complete blood counts, liver function, renal function; antiemetic prophylaxis recommended

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For institutional pricing, regulatory support, or bulk ordering of oncology molecules, please contact us at info@panamfarma.com.